The U.S. Department of Health and Human Services (HHS) is proposing consequences for healthcare providers who engage in information blocking under the 21st Century Cures Act.
Information blocking refers to actions that interfere with the access, exchange, or use of electronic health information (EHI) when needed for patient care. It applies to healthcare providers, health IT developers, and health information exchanges (HIEs). In October 2023, HHS published a proposed rule establishing disincentives for healthcare providers who are found to have engaged in information blocking.
An increased focus on information sharing
In 2015, the Office of the National Coordinator for Health Information Technology (ONC) reported an increasing trend of some healthcare entities limiting the sharing and access of EHI, known as information blocking, to Congress. In response to these concerns, Congress signed the 21st Century Cures Act into law in December 2016, which established the sharing of EHI as an expected norm. Four years later, HHS issued its final rule. In it, the Department defined key terms, discussed activities that would be likely to interfere with access, exchange, or use of EHI, and codified compliance with the information blocking rule.
In June 2023, the HHS Office of the Inspector General (OIG) implemented penalties of up to $1 million per violation for health IT developers of certified health IT, entities offering certified health IT, health information exchanges, and health information networks. Now, HHS is proposing to establish disincentives aimed at healthcare providers participating in certain Medicare-related programs.
Healthcare providers subject to proposed disincentives
Disincentives outlined in the proposal will only affect healthcare providers participating in the Medicare Interoperability Program, the Merit-Based Incentive Payment System (MIPS), and the Medicare Shared Savings Program (MSSP).
Medicare Interoperability Program
In 2011, the Centers for Medicare and Medicaid Services (CMS) established the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs to encourage providers to adopt, implement, upgrade, and demonstrate meaningful use of EHRs with the goal of improving patient access to health information. CMS later renamed the EHR Incentive Programs to the Medicare and Medicaid Promoting Interoperability Programs. In 2022, the Medicaid Promoting Interoperability Program ended. The program is now known as the Medicare Promoting Interoperability Program
In order for a hospital or critical access hospital (CAH) to participate in the program, the organization must meet the requirements to be a meaningful EHR user under federal law. HHS is proposing to amend the definition of a meaningful EHR user to disqualify eligible hospitals or CAHs if OIT determines that an entity has engaged in information blocking during both the concurrent reporting year and the calendar year. The impact on eligible hospitals would be the loss of 75% of the annual market basket increase.
Potentially impacted organizations include acute care hospitals, as most take part in the Promoting Interoperability Program. CAHs are also eligible to participate in the program. Other types of hospitals that provide inpatient care are not included in the CMS PI Program.
Merit-Based Incentive Payment System
CMS rewards Medicare MIPS eligible clinicians for providing high-quality, cost-effective services through the Quality Payment Program incentive program.
Clinicians are assessed in four categories to determine eligibility and the MIPS payment adjustment factor. One of them is the Promoting Interoperability performance category — which includes assessing whether a clinician is a meaningful user of certified electronic health record technology (CHERT).
CMS is proposing that a MIPS eligible clinician will earn a score of zero in the Promoting Interoperability performance category if the individual was found to have committed information blocking at any time during the calendar year of the performance period. A score of zero in the Promoting Interoperability performance period will cap a clinician’s performance score at 75 points. As the performance threshold for the 2026 MIPS payment year was proposed to be 82 points under the CY 2024 Physician Fee Schedule, a clinician found to have committed information blocking would receive a negative payment adjustment up to 9%.
Medicare Shared Savings Program
Medicare Shared Savings Program Accountable Care Organizations (ACOs) are groups of doctors, hospitals, and other healthcare providers who collaborate to give coordinated high-quality care to Medicare beneficiaries. When an ACO succeeds in both delivering high-quality care and spending healthcare dollars more wisely, the ACO may be eligible to share in the savings it achieves for Medicare.
Proposed disincentives may result in a healthcare provider being removed from an ACO or prevented from joining if they are found to have engaged in information blocking. Restricting the ability of healthcare providers to participate in the Shared Savings Program for at least one year would result in these health care providers potentially not receiving revenue that they might otherwise have earned if they had participated in the Shared Savings Program.
The proposed rule would potentially affect 450 ACOs participating in the MSSP with a total of 15,000 member organizations.
Investigation procedures
Under the proposed rule, HHS outlines that OIG will base its enforcement priorities for investigations of healthcare providers that have committed information blocking on the priorities finalized in OIG’s civil monetary penalties (CMP) final rule. These priorities include practices that (1) are causing, or have the potential to cause, patient harm; (2) have impacted a provider’s ability to provide patient care; (3) were of long duration; (4) resulted in financial loss to Federal healthcare programs or other private entities. HHS proposes to give OIG full autonomy in choosing which claims to investigate to ensure that resources are efficiently allocated to target claims that have the strongest negative effects.
HHS stresses the importance of transparency in investigations related to information blocking. Specifically, the Department is proposing to post the following information to the Office of the National Coordinator website: the OIG determination of information blocking, details on the provider, and the disincentive(s) applied.
HHS is requesting public comments in response to these proposed disincentives. Since the current proposal would only apply to a subset of healthcare providers, the Department is especially interested in comments regarding disincentives for other entities, such as pharmacies, laboratories, or post-acute care providers.
This information does not, and is not intended to, constitute legal advice; instead, all information are for general informational purposes only.
